11 TBS Endorsement by International Scientific Societies TBS in international guidelines TBS is officially recognised worldwide as an Independent fracture risk prediction tool

12 International Recommendations: ISCD & ESCEO Similar outcomes: TBS is associated with fracture, in women and men TBS predicts fracture independently from BMD, CRF and FRAX TBS predicts fracture in secondary osteoporosis context type 2 diabetes (ISCD), hyperpara & Glucocorticoid induced OP (ESCEO) TBS should not be used alone to determine treatment recommendations in clinical practice. No guidelines on TBS and treatment monitoring and selection yet Major Conclusion: «TBS has «a role in fracture risk assessment with both abmd and FRAX» and enables to «enhance risk stratification with abmd» TBS insight is now also in local guidelines: German DVO & Swiss ASCO

19 International recommendations: «FRAX Adjusted for TBS» FRAX Group Study Outcome: TBS has a role in a combination model with FRAX to reclassify patients at risk, and especially for those considered at intermediate risk likely to switch from one side to the other of the intervention threshold. Eugene McCloskey Quote in the IOF Press Release April 2014: By fine tuning the information provided by FRAX, TBS adjusted FRAX gives clinicians more precise information that can aide them in making informed treatment decisions within the course of a clinical assessment. Available online on Sheffield calculation tool since April 15th; www. Shef.ac.uk/FRAX 1 (Model): Adjust fracture probability by Trabecular Bone Score, E.V. McCloskey et al. CTI (Validation): A meta-analysis of trabecular bone score in fracture risk prediction and its relationship to FRAX, E.V. McCloskey et al., JBMR 2015

23 TBS into International Guidelines German DVO Since the end of 2014, TBS is included in German osteoporosis guidelines (DVO) as a clinical risk factor

24 TBS into International Guidelines German DVO A-73 year-old woman with a BMD T-score of -2.4 and without any other clinical risk factor should not be treated (as presented in the table below, green highlight). This patient has a L1-L4 TBS of (TBS Z-score of -2). Based on the DVO recommendations, this patient is now eligible for treatment (as presented in the table below, red highlight).

25 Can TBS be used to monitor changes across time and particularly for treatments follow-up? Differential effect upon the molecule

30 Effects of GCs on bone health Cross sectional study 416 subjects aged 40 years and over who received GCs ( 5 mg/day, for 3 months) 1104 matched control subjects : gender, age (±3 yrs) and BMI (± 2kg/m²) Matching 1:1 for men (n= 72) and 1:3 for women (n=344) Control subjects were included if they had an abmd with a Z-score from -2 to +2 SD Any low trauma fracture was considered for this study except for fractures of fingers, toes and skull. Leib E. Osteoporos Int 2015

44 Neil 'case Treatment category switch based on FRAX adjusted for TBS Jane Doe is a 65 year-old white female who is concerned about her mother recently fell and sustained a hip fracture. Her mother had previously 3 VF, the first of which occurred at age 68. Mrs Does is generally healthy taking only a statin for hyperlipidemia. Her diet provides ~1000 mg of calcium and she takes 1000 IU of suppl. Vit D3 daily. Shes does not smoke, drinks one glass of wine daily and walks for abut 30 minutes 3 to 5 times a week. Her menopause was at age 48 and she never received HRT. She has no personal history of fragility fracture, history of RA or GC use. Her physical examination is unrevealing; Height 158 and weight 57 kg Laboratory evaluation included serum calcium, creatinine, phosphorous, PTH and 25 (OH)D, all of which were normal Osteopenic BMD: Spine L1-4 T-score = -1,8 & Femoral neck T-score = -1,7 Degraded structure: Spine L1-4 TBS = 1,120

47 Neil 'case Treatment category switch based on FRAX adjusted for TBS In this individuals, the estimated 10 year probability of major OP related fracture is 17%. Based on this, she does not meet current NOF guidelines for therapy. However, her TBS is very low (classification: degraded microarchitecture) The 10 years probability of major osteoporotic related fracture adjusted for TBS is 21%. Based upon this, she does meet treatment guidelines

48 Berengere 'case Impact of GC on TBS Jane Doetoo is a 58 year-old white female with Polyarthritis Rheumatoid for the last 25 years (erosive positive). She had 2 total knees and 1 elbow implants. She is receiving classical PR treatment: Methotrexate & Atemra Osteopenic BMD: Spine L1-4 T-score = -1.3 & Femoral neck T-score = -1.7 Normal/partially degraded structure: Spine L1-4 TBS = 1,311 FRAX is for MOF at 11% and 1.3% for hip fracture probability Adjusted for TBS: 11% and 1.2%, respectively 2 years after, Jane had a major PR flare She then received daily dose of gluco-corticoid (15 mg), then 10 then 5

49 GC Initiation

50 No bone specific treatment was given She ended up with hip fracture from standing height fall!!

51 Conclusions

52 Are we taking care of osteoporosis OR do we want to prevent osteoporotic fracture

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